K883783 is an FDA 510(k) clearance for the TSRH SACRAL SPINAL SCREW. This device is classified as a Appliance, Fixation, Spinal Interlaminal (Class II - Special Controls, product code KWP).
Submitted by Warsaw Orthopedic, Inc. (Warsaw, US). The FDA issued a Cleared decision on April 6, 1989, 212 days after receiving the submission on September 6, 1988.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3050.
| 510(k) Number | K883783 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | September 06, 1988 |
| Decision Date | April 06, 1989 |
| Days to Decision | 212 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | KWP — Appliance, Fixation, Spinal Interlaminal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3050 |